Ultrasound Needle Transducer for Regional Anesthesia Validation Study
- Conditions
- Pain, PostoperativeUltrasound Therapy; ComplicationsThorax; Pain, Spine, With Radicular and Visceral PainAcute Post-thoracotomy Pain
- Interventions
- Procedure: Intercostal nerve blocksProcedure: Paravertebral block
- Registration Number
- NCT04726930
- Lead Sponsor
- Taipei Veterans General Hospital, Taiwan
- Brief Summary
To validate the efficacy of miniaturized ultrasound needle transducer as the primary guide for thoracic regional anesthesia.
- Detailed Description
Paravertebral (PVB) and intercostal nerve block (ICNB) are both techniques of injecting local anesthetics for pain management at thoracic and upper abdominal region.
Today, PVB and ICNB are performed under the guidance of surface two dimensional B-mode ultrasound. However, the procedure still carries potential risks for inexperienced operators since the target zone is very close (2-3 mm) to the pleura. In certain patients, such as those with obesity, the steep needle trajectory and poor quality of the anatomic image make the nerve block even more difficult.
Inaccurate identification of the anatomical structures or suboptimal positioning of the needle tip could result in complications and blockade failure.
We designed an intra-needle ultrasound (INUS) system to improve the identification of anatomical structures and needle tip position. The system passed all safety standards including electrical safety test, biocompatibility test, software certification.
This study is to investigate the feasibility and image quality of INUS during ICNB and PVB. The study protocol is approved and under monitoring for safety and compliance from both Institutional Review Board of Taipei Veterans General Hospital and Ministry of Health and Welfare, Taiwan, Republic of China.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Patients scheduled for elective thoracic surgery
- Patients scheduled for elective upper abdominal surgery
- Patients scheduled for elective breast surgeries.
- Known coagulopathies,
- Skin lesion or infection at site of nerve block
- Pregnant women
- Allergic to local anesthetics
- Cognitive diseases
- Unstable hemodynamics
- Chronic substance abuse (ex. alcohol, hypnotics, opioids)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Intercostal nerve block with surface ultrasound Intercostal nerve blocks Number of participants: 10 Intercostal blocks will be performed under guidance of surface ultrasound. After we reach the injection site, the puncture stylet will be replace by Intra-needle ultrasound transducer (INUS). Collect signal from Intra-needle ultrasound transducer and then inject local anesthetics. Code name: ICNB-INUS-check Paravertebral block with surface ultrasound Paravertebral block Number of participants: 10 Paravertebral blocks will be performed under guidance of surface ultrasound. After we reach the injection site, the puncture stylet will be replace by Intra-needle ultrasound transducer (INUS). Collect signal from Intra-needle ultrasound transducer and then inject local anesthetics. Intercostal nerve block with intra-needle and surface ultrasound Intercostal nerve blocks Number of participants: 10 Intercostal blocks will be performed under guidance of intra-needle "and" surface ultrasound. The intra-needle transducer will be placed inside the puncture needle and it will be the primary guidance to reach target injection site. Surface ultrasound will be the secondary image guide for simultaneous comparison. Collect signal from both Intra-needle ultrasound transducer and surface ultrasound, and then inject local anesthetics. Code name: ICNB-INUS-guide Paravertebral nerve block with intra-needle and surface ultrasound Paravertebral block Number of participants: 10 Paravertebral blocks will be performed under guidance of intra-needle "and" surface ultrasound. The intra-needle transducer will be placed inside the puncture needle and it will be the primary guidance to reach target injection site. Surface ultrasound will be the secondary image guide for simultaneous comparison. Collect signal from both Intra-needle ultrasound transducer and surface ultrasound, and then inject local anesthetics. Code name: PVB-INUS-guide
- Primary Outcome Measures
Name Time Method Needling time Needle insertion to needle withdrawal, up to 20 minutes Needle insertion to needle withdrawal (minutes)
Nerve block procedure time Time from ultrasound contact with skin to needle withdrawal, up to 20 minutes How long the procedure takes in minutes, starting from ultrasound contact with skin to needle withdrawal
Success rate of blockade 20 minutes post administration of local anesthetics (by ultrasound or cold sensation) or intraoperative (at the time of video-thoracoscope exploration) Successful blockade will be determined by 1.ultrasound evidence of ideal spreading or 2.evidence of fluid accumulation around intercostal nerves or at paravertebral space under thoracoscope, or 3. loss of cold sensation on the chest or abdomen at block level.
Visibility of needle tip and anatomic structure During block procedure, up to 60 minutes. Record the visibility of needle tip, intercostal muscle, superior costotransverse ligament, pleura. Assessed by the inserting anesthetist on a 5 point Likert scale
- Secondary Outcome Measures
Name Time Method Inadvertent pleural puncture or pneumothorax 20 minutes post-procedure or intraoperative (if needle injuries on pleura noted by thoracoscope) Calculate the rate of Inadvertent pleural puncture or pneumothorax, defined by image evidence of pleura injuries or pneumothorax by thoracoscope, X-ray, or CT.
Trial Locations
- Locations (1)
Taipei Veterans General Hospital
🇨🇳Taipei city, Taiwan, R.o.c., Taiwan